Extended-release minoxidil pill (VDPHL01): what the 2026 phase 3 results mean for Malaysians

In October 2026 a US company reported that a new once-a-day minoxidil pill, VDPHL01, beat placebo in a large Phase 3 trial in men with pattern hair loss. Headlines called it the first new hair loss pill in decades. In Malaysia the news quickly turned into practical questions: is this the same as the low-dose minoxidil tablets some doctors already prescribe, can it be bought here, and should anyone stop what they are doing now and wait for it?

This guide explains what an extended-release minoxidil pill is, what the trial actually measured, how it compares with topical minoxidil and with ordinary low-dose oral minoxidil, and what a sensible plan looks like for a Malaysian reader today. It is general information, not personal medical advice. For background, see low-dose oral minoxidil and how to read hair research news.

The short answer

• VDPHL01 is minoxidil, not a new molecule. It is an oral, extended-release form of the same drug used in hair foams and lotions, designed to release slowly instead of all at once ¹.
• The Phase 3 result was clearly positive at six months. In 536 men, average non-vellus hair counts rose by 28.6 hairs/cm² on once-daily dosing and 36.4 hairs/cm² on twice-daily dosing, against 6.6 hairs/cm² on placebo ¹.
• It is not approved anywhere yet. The trials are still running, longer safety data are pending, and a separate trial in women is expected to report in 2027 ^{1 2}.
• Low-dose oral minoxidil already exists, off-label. Doctors in many countries prescribe ordinary minoxidil tablets at small doses for hair, guided by an international expert consensus ^{3 4}.
• The proven basics still apply. Topical minoxidil and, for men, finasteride remain the best-studied treatments for pattern hair loss ^{5 6}.
• Waiting has a cost. Pattern hair loss is gradual, and follicles that shrink for years are harder to bring back, so delaying all treatment for a pill that is not yet available is rarely wise ⁶.

What VDPHL01 is

Minoxidil was first developed as a blood pressure tablet. The hair growth seen in people taking it led to the topical solutions and foams sold today ⁷. In the last decade, dermatologists have also started prescribing ordinary minoxidil tablets at very low doses, often a fraction of the blood pressure dose, for hair loss. This is called low-dose oral minoxidil, or LDOM, and it is "off-label": the tablets are licensed for blood pressure, not for hair ^{8 3}.

VDPHL01 is a new tablet of minoxidil made by Veradermics, a US company. The difference is in how the drug is released. Ordinary minoxidil tablets are "immediate release": they dissolve quickly and produce a peak in blood levels a short time after each dose. VDPHL01 is an extended-release formulation intended to release minoxidil gradually. The idea, as a dermatologist who was not involved in the trial (and who disclosed an advisory role with the company) explained to Medscape, is that lower peaks might reduce side effects linked to those peaks, such as dizziness or changes in blood pressure ¹. That is a reasonable hypothesis, but it has not yet been proven in a head-to-head trial against ordinary LDOM.

The developer is seeking approval from the US Food and Drug Administration (FDA) and describes VDPHL01 as potentially the first FDA-approved oral pill for pattern hair loss in nearly 30 years. No approval has been granted, and the company had not announced a submission date when the results were reported ¹.

How minoxidil works on the hair follicle

The hair cycle in brief

Each hair follicle cycles through a long growing phase (anagen), a short transition (catagen) and a resting phase (telogen), after which the old hair sheds and a new one starts ⁹. On the scalp, anagen normally lasts several years, which is what lets hair grow long.

What goes wrong in pattern hair loss

In androgenetic alopecia, the male hormone dihydrotestosterone (DHT) acts on genetically sensitive follicles, mainly at the temples, crown and top of the head. With each cycle, the growing phase becomes shorter and the follicle becomes smaller. Thick, pigmented "terminal" hairs are gradually replaced by thin, short, pale "vellus-like" hairs. This shrinking process is called miniaturisation ⁶. In women the pattern is usually a widening parting with a preserved front hairline, and the role of hormones is more complex ⁶.

What minoxidil does

Minoxidil does not block DHT. It works on the follicle itself. It is a "prodrug": enzymes called sulfotransferases convert it into its active form, minoxidil sulfate. Its effects are thought to come mainly from opening potassium channels in the follicle, along with effects on blood vessels and on signals that prolong the growing phase ^{7 4}. The result is that more follicles stay in anagen for longer and some miniaturised follicles grow thicker hairs.

This also explains why some people do not respond well to topical minoxidil: their scalp has low sulfotransferase activity, so less of the drug is converted. Taken by mouth, minoxidil is converted largely in the liver, which is one reason oral forms can help some people who did poorly with lotions or foams ⁷.

Why "non-vellus hair count" matters

The main measurement in VDPHL01's trial was non-vellus target area hair count: the number of thicker, non-vellus hairs in a marked area of scalp, per square centimetre. It is a standard way to track whether follicles are making thicker hairs. Because the trial counted thicker hairs only, an increase means more hairs moving out of the miniaturised state, not just more fuzz ^{1 10}.

What the Phase 3 trial found

The trial, called Study 304, is registered as NCT06972264 ¹⁰. It enrolled 536 men with mild-to-moderate male pattern hair loss and randomly assigned them to VDPHL01 8.5 mg once a day, VDPHL01 8.5 mg twice a day, or placebo for six months ¹. According to the company's announcement, as reported by Medscape:

• Hair count: average increases of 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily), compared with 6.6 hairs/cm² for placebo. Both doses were statistically superior to placebo ¹.
• How men rated their own hair: 55.7% (once daily) and 68.7% (twice daily) rated their hair coverage "improved" or "much improved", against 15.0% on placebo. Counting any improvement, the figures were 78.8% and 85.0% against 35.3% ¹.
• How investigators rated it: blinded investigators graded 78.4% and 82.7% of men as having improved hair coverage at six months ¹.
• Speed: some improvements were seen as early as month two, the first time point measured ¹.
• Safety: the drug was described as generally well tolerated, with no treatment-related serious adverse events and no cardiac adverse events of special interest ¹.

What these numbers do and do not tell you

These are strong results for a six-month placebo-controlled trial. But a few cautions are worth keeping in mind:

• Topline results come from the company. Full data have not yet been published in a peer-reviewed journal, where methods and side effect tables can be checked in detail.
• The comparison is with placebo, not with existing treatments. The trial does not show that VDPHL01 works better than topical minoxidil, ordinary LDOM or finasteride.
• Six months is a short time. The registered trial continues beyond the placebo-controlled phase, and the company expects 12-month safety data in men later in 2026 ^{1 10}.
• The men were carefully selected. The trial excluded people with conditions such as uncontrolled blood pressure and certain heart problems, so results may not apply to everyone ¹⁰.

An earlier Phase 2/3 trial in men, Study 302 (NCT06724614), is also registered ¹¹, and a Phase 3 trial in women, Study 306 (NCT07146022), has enrolled roughly 550 participants, with results expected in 2027 ^{2 1}.

First, make sure it is pattern hair loss

Every minoxidil product, new or old, is aimed at pattern hair loss. Other causes need different care, and some need it urgently ¹²:

• Telogen effluvium: sudden, diffuse shedding two to three months after a fever, dengue, surgery, childbirth, crash dieting or major stress.
• Alopecia areata: smooth, round bald patches, sometimes in the beard or eyebrows.
• Scarring alopecias: redness, pain, scaling or shiny skin where hair is lost; these need a dermatologist quickly.
• Medical causes: thyroid problems, iron deficiency and some medicines can all cause or worsen shedding.

A doctor or dermatologist can usually tell the difference by examining the scalp, sometimes with a dermatoscope, and may order blood tests. That step comes before any decision about pills.

How the minoxidil options compare

Topical minoxidil versus oral minoxidil

A 2024 randomised trial in 90 men compared 5 mg oral minoxidil once a day with 5% topical minoxidil twice a day for 24 weeks. Oral minoxidil did not prove superior overall; it did better only on the photographic assessment of the crown. Almost half of the men on oral minoxidil developed hypertrichosis (extra body or facial hair) ¹⁶. A 2025 review concluded that oral minoxidil has comparable efficacy to topical minoxidil, with the added advantages of better adherence, lower cost and fewer application-related side effects ⁴.

In practice, the pill's main advantage is often adherence: many people find a tablet easier than applying a liquid or foam twice a day in a hot, humid climate.

Pros, cons and risks

Possible advantages of an extended-release pill

• One or two tablets a day instead of applying a product to the scalp.
• No sticky residue, no scalp irritation from the vehicle, no effect on hairstyle.
• Possibly smoother blood levels than ordinary tablets, which might reduce peak-related side effects; this still needs proof ¹.
• If approved, a formal licence for hair loss, with standard dosing and product information.

Disadvantages and open questions

• Not available yet, and no Malaysian timeline has been announced.
• Long-term safety beyond the trials is still being collected.
• Likely to need a prescription and medical follow-up, as oral minoxidil does today.
• Cost is unknown; nothing has been announced.

Known risks of oral minoxidil in general

In a multicentre study of 1,404 patients taking low-dose oral minoxidil, the most frequent side effect was hypertrichosis (15.1%). Systemic side effects included lightheadedness (1.7%), fluid retention (1.3%), fast heartbeat (0.9%) and headache (0.4%). Only 1.7% stopped treatment because of side effects, and no life-threatening events were seen. The study was retrospective and had no control group ¹⁵. Reviews list pericardial disease, uncontrolled high blood pressure and pregnancy among the reasons not to use oral minoxidil ⁴.

Typical timelines

• Weeks 2 to 8: some people notice extra shedding as resting hairs are pushed out to make way for new growth. This is usually temporary ⁴.
• Month 2: in the VDPHL01 trial, the earliest measured improvements were seen at this point ¹.
• Months 4 to 6: a fair point to judge visible change with standardised photos. The VDPHL01 primary results were measured at six months ¹.
• Month 12 and beyond: benefits generally need continued use. Stopping minoxidil in any form usually means the gained hair is gradually lost again over the following months ⁷.
• Regulatory timeline: 12-month safety data in men were expected later in 2026 and data in women in 2027; any approval would come after that, and Malaysian registration would be a separate process ^{1 17}.

The Malaysian context

Availability. Medicines sold in Malaysia must be registered with the National Pharmaceutical Regulatory Agency (NPRA). You can check whether a product is registered on the NPRA's QUEST product search ¹⁷. VDPHL01 is not approved by the FDA and has no Malaysian registration. Any website or seller offering "extended-release minoxidil for hair" today is not selling the trial drug, and unregistered pills bought online carry real risks.

Climate. Malaysia's heat and humidity make twice-daily lotions harder to stick with: products drip with sweat, hair looks greasy, and helmets, tudung and caps rub the scalp. This is one reason pill forms attract interest. A foam, which dries faster than a solution, is another way people handle this.

Blood pressure and the heart. Many adults have high blood pressure without knowing it. Because oral minoxidil lowers blood pressure and can cause fluid retention, a doctor should check blood pressure, heart rate and medical history before prescribing any oral form ³.

Cost. This article does not list prices. No price has been announced for VDPHL01, and the cost of current treatments varies by clinic and pharmacy; for current topical options, see minoxidil prices in Malaysia.

Where to go. Start with a GP or a dermatologist registered with the Malaysian Medical Council; the MMC register lets you check a doctor's registration ¹⁸. A dermatologist can confirm the diagnosis, discuss topical or oral minoxidil and finasteride, and tell you when a new drug becomes a real option.

Common myths

• "It is a brand-new drug." No. It is minoxidil in a new release form ¹.
• "It works better than anything available now." The trial compared it with placebo only. There is no head-to-head evidence against topical minoxidil or ordinary low-dose tablets yet.
• "Extended release means no side effects." Lower peaks may help, but it is still minoxidil. Extra body hair, shedding and fluid retention are known effects of oral minoxidil in general ¹⁵.
• "You can buy it online." It is an investigational drug with no approval. Anything sold under that description now is not the trial product.
• "Once the hair grows back, you can stop." Minoxidil works only while it is being used ⁷.
• "Pills are for men only." A dedicated trial in women is under way, and ordinary low-dose oral minoxidil is already prescribed to women by some doctors, usually at lower doses ^{2 4}.

A practical checklist

1. Confirm the diagnosis. Make sure it is pattern hair loss and not shedding, patches or scarring.
2. Take baseline photos. Same light, same angles, hair dry, every three months.
3. Start or continue a proven treatment. Do not stop a working routine to wait for a pill that is not yet available.
4. Ask about oral minoxidil if lotions are hard to keep up. Low-dose tablets are an option a doctor can discuss now, with checks first ³.
5. Know your blood pressure and heart history. Share medicines and conditions with the doctor.
6. Never buy unregistered pills online. Check registration on NPRA QUEST ¹⁷.
7. Judge results at six months, not six weeks.
8. Follow the news calmly. Look for peer-reviewed publication and regulatory approval, not just headlines.

The bottom line

VDPHL01 is a real advance in how minoxidil can be delivered, backed by large placebo-controlled trials with clearly positive six-month results. It is also still an investigational medicine: not approved in the US, not registered in Malaysia, and not yet compared directly with the treatments people use today. For most Malaysians with pattern hair loss, the most useful step right now is a proper diagnosis and a steady routine with treatments that are already available, and then a conversation with a doctor if and when the new pill reaches the market.

Frequently asked questions

What is VDPHL01?

An investigational extended-release tablet of minoxidil, the same drug used in hair lotions and foams, designed to release slowly through the day. It is being developed by Veradermics in the US.

Is VDPHL01 approved or available in Malaysia?

No. It is not approved by the US FDA and has no Malaysian registration. Products sold online under that description are not the trial drug.

How well did it work in the Phase 3 trial?

In 536 men, average thicker-hair counts rose by 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) at six months, compared with 6.6 on placebo. These are topline company results, not yet published in full.

Is it better than low-dose oral minoxidil tablets?

That is not known. The trial compared VDPHL01 with placebo only. Lower peak blood levels might mean fewer side effects, but this has not been tested head to head.

Can I get oral minoxidil now?

Ordinary minoxidil tablets can be prescribed off-label at low doses by a doctor after checking blood pressure, heart health and medicines. It should never be self-prescribed.

What side effects does oral minoxidil cause?

Extra body or facial hair is the most common. Less often: lightheadedness, fluid retention, a fast heartbeat and headache. Serious effects are rare at hair loss doses.

Is there a version for women?

A Phase 3 trial of VDPHL01 in women, with roughly 550 participants, is under way, with results expected in 2027.

Should I stop my current treatment and wait?

Usually not. Pattern hair loss is gradual, and hair kept today is easier to maintain than hair lost while waiting. Discuss any change with a doctor.

Educational content. Not medical advice.